Disposable Biopsy Valve

K173758 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · OCX · May 14, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K173758
• Device Name: Disposable Biopsy Valve
• Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
• Product Code: OCX · Gastroenterology, Urology
• Decision Date: May 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Disposable Biopsy Valve is used to cover the biopsy/suction channel of Olympus® and Fujinon® or Pentax® gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

Device Story

Disposable biopsy valve; attaches to biopsy/suction channel of gastrointestinal endoscopes. Device consists of cylindrical base, cap, and flexible diaphragm seal. Functions as mechanical interface; allows passage of surgical instruments while maintaining seal to prevent fluid leakage and maintain insufflation pressure. Cap allows pressure modification during insufflation. Used in clinical settings by endoscopists/technicians during endoscopic procedures. Provides leak-free access for instruments and irrigation; benefits patient by maintaining insufflation and preventing leakage of biomaterial during procedures.

Clinical Evidence

Bench testing only. Performance verified via pressure testing (holding 10 PSI for 1 minute) with valve closed, with instrument inserted, and following instrument removal. Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity, sensitization, intracutaneous injection, and systemic injection tests.

Technological Characteristics

Thermoplastic elastomer construction; single-piece injection molded. Dimensions: 0.071" inner diameter. Mechanical sealing via flexible diaphragm. Compatible with Olympus, Fujinon, and Pentax gastrointestinal endoscopes. Sterilization: EO gas. Non-sterile or sterile supply.

Indications for Use

Indicated for use with Olympus, Fujinon, or Pentax gastrointestinal endoscopes to cover the biopsy/suction channel, facilitate endoscopic device passage/exchange, maintain insufflation, minimize biomaterial leakage, and provide irrigation access.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Medovations BullDog® Biopsy Valves (K142068)
• Seal Single-use Biopsy Valve (K161167)

Submission Summary (Full Text)

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May 14, 2018

Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long Quality Supervisor 301B, No.22, XinYan Road Hanzhou. Zhejiang 311100 China

Re: K173758

Trade/Device Name: Disposable Biopsy Valve Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: OCX Dated: April 18, 2018 Received: April 18, 2018

Dear Lucius Long:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the overall impression is clean and professional.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K173758

Device Name Disposable Biopsy Valve

Indications for Use (Describe)

The Disposable Biopsy Valve is used to cover the biopsy/suction channel of Olympus® and Fujinon® or Pentax® gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

Type of Use (Select one or both, as applicable)

| <div><span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CER 801 Subpart D)</div> |
|---------------------------------------------------------------------------------------------------------------------|
| <div><span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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Image /page/3/Picture/1 description: The image contains a logo with a hexagon shape on the left side that transitions from green to blue. To the right of the hexagon is the text "MEDNOVA" in blue. Above the text "MEDNOVA" are three Chinese characters in blue.

Zheiiang Chua al Technology Co.,Ltd

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# Section 3 510(k) Summary( 21CFR 807.92)

# 1. Submitter's information

Name: Zhejiang Chuangxiang Medical Technology Co., LTD.

Address: 301B, No.22, XinYan Road Yuhang Economic And Technological Development Zone Hangzhou Zhejiang China

Contact person: Lucius.Long Telephone: [phone] Fax: [phone]

# 2. Device

Trade Name: Disposable Biopsy Valve Common Name: Disposable Biopsy Valve Regulation class: 2 Panel: Gastroenterology/Urology Classification name: Endoscope and accessories Regulation number:876.1500 Product code: OCX

# 3. Predicative device

3.1) 510(k) Number:K142068, Product Name: Medovations BullDog® Biopsy Valves 3.2) 510(k) Number: K161167, Product Name: Seal Single-use Biopsy Valve

# 4. Device description

The Disposable Biopsy Valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Disposable Biopsy Valve provides sealable access via the working channel port of an endoscope for surgical instruments. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free. The valve is designed with a hollow body with a distal end that releasably attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted

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Image /page/4/Picture/1 description: The image shows the logo for MEDNOVA. The logo consists of a hexagon with a gradient of green and blue, with a white line inside. To the right of the hexagon is the text "MEDNOVA" in blue and green. Above the text is Chinese characters in blue.

#### ical Technology Co.,Ltd Zheiiang Chuan

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through the opening, preventing fluids from passing through the biopsy valve. The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.

# 5. Indication for use

The Disposable Biopsy Valve is used to cover the opening to the biopsy/suction channel of Olympus® and Fujinon® or Pentax® gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

# 6. Technological Characteristics

The Disposable Biopsy Valve incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate devices.

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Image /page/5/Picture/1 description: The image contains a logo for Zhejiang Chuangxiang Medical Technology Co., Ltd. The logo features a stylized hexagonal shape in gradient blue and green, with a white line running through it. To the right of the shape are Chinese characters and the word "MEDNOVA" in blue. Below the logo is the company name, "Zhejiang Chuangxiang Medical Technology Co.,Ltd" in black.

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# Comparison to predicate Devices:

| Item | Proposed device | Primary Predicate device | Additional Predicate<br>device | Comparison to<br>Predicate Devices |
|-------------------------|------------------------------------------------------|---------------------------------------|----------------------------------|------------------------------------|
| Device name | Disposable Biopsy Valve | Medovations BullDog®<br>Biopsy Valves | Seal Single-use Biopsy<br>Valve | Similiar |
| 510(k) number | NA, new submission | K142068 | K161167 | Different 510(k)<br>number |
| Manufacturer | Zhejiang Chuangxiang<br>medical technology Co., Ltd. | Medovations, Inc. | Endochoice, Inc. | Different<br>manufacturer |
| Product Code | OCX | OCX | OCX | Same |
| Regulation No. | 876.1500 | 876.1500 | 876.1500 | Same |
| Class | 2 | 2 | 2 | Same |
| Regulation<br>Name | Single piece injection<br>molded | Single piece injection<br>molded | Single piece injection<br>molded | Same |
| Supplied Sterile | non-sterile or sterile | non-sterile or sterile | non-sterile or sterile | Same |
| Sterilization<br>method | EO gas | EO gas | EO gas | Same |
| Material | Thermoplastic elastomer | Thermoplastic elastomer | Thermoplastic elastomer | Same |
| Valve Inner<br>Diameter | .071" | .065" | 7.1 mm | Similar |

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Image /page/6/Picture/1 description: The image contains the logo for MEDNOVA. The logo consists of a green and blue hexagon shape on the left, with the text "MEDNOVA" in blue on the right. Above the text "MEDNOVA" are three Chinese characters in blue.

# Zhejiang Chuangxiang Medical Technology Co.,Ltd

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| Removable Cap with<br>Slit for Device<br>Passage | | | | |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------|
| | Yes | Yes | Yes | Same |
| Slit<br>accommodate<br>devices | Up to 3.2 mm | / | Up to 3.2 mm | Same |
| Biocompatibility | Tested in accordance with ISO<br>10993-1 | No direct patient contact.<br>Indirect patient contact from<br>devices and/or irrigating<br>solution that is in contact with<br>the biopsy valve and accessory<br>irrigating adaptor. | Tested in accordance with<br>ISO 10993-1 | Same |
| Endoscope<br>compatibility | Molded versions to fit<br>biopsy/suction channel of<br>Olympus/Fujinon<br>gastrointestinal endoscopes<br>or biopsy/suction channel of<br>Pentax gastrointestinal<br>endoscopes | Molded versions to fit<br>biopsy/suction channel of<br>Olympus/Fujinon<br>gastrointestinal endoscopes or<br>biopsy/suction channel of<br>Pentax gastrointestinal<br>endoscopes | Olympus series 160, 180,<br>and 190. Fujinon series 530,<br>590, and 600. EndoChoice<br>Fuse gastrointestinal<br>endoscopes | Same |

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Image /page/7/Picture/1 description: The image contains a logo for MEDNOVA. The logo consists of a stylized hexagon shape in green and blue gradient, followed by the text "MEDNOVA" in blue and green. To the right of the text is Chinese characters in blue.

# Zhejiang Chuangxiang Medical Technology Co.,Ltd

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| Indications for<br>Use | The Disposable Biopsy Valve<br>is used to cover the opening<br>to the biopsy/suction channel<br>of Olympus® and Fujinon® or<br>Pentax® gastrointestinal<br>endoscopes. It provides<br>access for endoscopic device<br>passage and exchange, helps<br>maintain sufflation,<br>minimizes leakage<br>of biomaterial from the<br>biopsy port throughout the<br>endoscopic procedure, and<br>provides access for irrigation. | The single use BullDog® Biopsy<br>Valve is used to cover the<br>opening to the biopsy/suction<br>channel of Olympus® and<br>Fujinon® or Pentax®<br>gastrointestinal endoscopes.<br>It provides access for<br>endoscopic device passage<br>and exchange, helps maintain<br>sufflation, minimizes leakage<br>of biomaterial from the biopsy<br>port throughout the<br>endoscopic procedure, and<br>provides access for irrigation. | The Single-Use Biopsy Valve<br>provides access for<br>endoscopic device passage<br>and exchange, helps<br>maintain sufflation, and<br>minimizes leakage of<br>biomaterial from biopsy<br>port throughout the<br>endoscopic procedure, and<br>provides access for<br>irrigation. | Same |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Single Use | Yes | Yes | Yes | Same |
| Packaging | BILLERUD (2010)70g pouch<br>with 52μm PE/PET | Tyvek pouch with a<br>polyethylene film | Tyvek pouch with a<br>polyethylene film | Similar |
| Performance testing | Design verification Pressure<br>test with valve closed - the<br>device holds pressure for 1<br>Min at 10 PSI | / | Design verification Pressure<br>test with valve closed - the<br>device holds pressure for 1<br>Min at 10 PSI | Same |

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Image /page/8/Picture/1 description: The image shows a logo for MEDNOVA. The logo consists of a green and blue hexagon shape on the left, with the text "MEDNOVA" in green and blue to the right of the shape. Above the text "MEDNOVA" are some Chinese characters in blue.

# Zhejiang Chuangxiang Medical Technology Co.,Ltd

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| Design verification Pressure<br>test with instrument inserted<br>- the device holds pressure<br>for 1 Min at 10 PSI | / | Design verification Pressure<br>test with instrument<br>inserted - the device holds<br>pressure for 1 Min at 10 PSI | Same |
|---------------------------------------------------------------------------------------------------------------------------|---|------------------------------------------------------------------------------------------------------------------------------|------|
| Design verification Pressure<br>test: Following removal of<br>instrument the device holds<br>pressure for 1 Min at 10 PSI | / | Design verification Pressure<br>test:<br>Following removal of<br>instrument the device holds<br>pressure for 1 Min at 10 PSI | Same |

The main difference is the dimension about Valve Inner , because their criteria are different. The inneter criterion of primary predicate device is 1.651mm (.065") and the proposed device is1.81mm(.071"). But they each meet their own design requirements, usually, the O.D. of the devices ≥2.0mm used cooperatively with the inner diameter of the biopsy valve. So we think the proposed device meet the Clinical requirements, the proposed device and predicate device are substantial equivalent.

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Image /page/9/Picture/1 description: The image shows the logo for Zhejiang Chuangxiang Medical Technology Co., Ltd. The logo features a geometric shape in shades of green and blue, along with the company name in both Chinese and English. The English name, "MEDNOVA," is prominently displayed below the Chinese characters.

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# 7. Non-Clinical Testing:

The device has undergone both bench testing of performance and laboratory biocompatibility testing for cytotoxicity, sensitization, intracutaneous injection test, and system injection test, in accordance with 21 CFR, Part 58. The Single Use Biopsy Valve results in no safety or efficacy concerns regarding biocompatibility or performance. Likewise, in conformance with 21 CFR 807.92(b)(3), the device performs as well as the predicate in all testing performed.

# 8. Conclusions

Chuangxiang medical has demonstrated that the proposed Disposable Biopsy Valve is substantially equivalent to Medovations and Endochoice, Inc. currently marketed Medovations BullDog® Biopsy Valves (K142068) and Seal Single-use Biopsy Valve (K161167).